Prosthetic valve for transluminal delivery

ABSTRACT

A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. When the outer sheath is retracted, the prosthetic valve assembly expands to an expanded position such that the valve and valve support expand within the deficient native valve, and the anchor engages the lumen wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.13/010,010, filed Jan. 20, 2011, which is a continuation of U.S.application Ser. No. 12/348,892, filed Jan. 5, 2009, which is acontinuation of U.S. application Ser. No. 12/029,031, filed Feb. 11,2008, which is a continuation of U.S. application Ser. No. 11/352,614filed Feb. 13, 2006, now U.S. Pat. No. 7,329,278, which is acontinuation of U.S. application Ser. No. 10/412,634 filed Apr. 10,2003, now U.S. Pat. No. 7,018,406, which is a continuation-in-part ofU.S. application Ser. No. 10/130,355, now U.S. Pat. No. 6,830,584, whichhas a 371(c) date of Nov. 26, 2002, and is the U.S. national phase under§371 of International Application No. PCT/FR00/03176, filed on Nov. 15,2000, which was published in a language other than English and whichclaimed priority from French Application No. 99/14462 filed on Nov. 17,1999, now French Patent No. 2,800,984; this application is also acontinuation-in-part of International Application No. PCT/FR01/03258filed on Oct. 19, 2001, which was published in a language other thanEnglish. The present application is also a continuation-in-part of U.S.application Ser. No. 10/772,101, filed Feb. 4, 2004, which is acontinuation-in-part of U.S. application Ser. No. 10/412,634, filed Apr.10, 2003, now U.S. Pat. No. 7,018,406, which is (1) acontinuation-in-part of U.S. application Ser. No. 10/130,355, filed onMay 17, 2002, now U.S. Pat. No. 6,830,584, which is the U.S. Nationalphase under §371 of International Application No. PCT/FR00/03176, filedon Nov. 15, 2000, which was published in a language other than Englishand which claimed priority from French Application No. 99/14462, filedon Nov. 17, 1999, now French Patent No. 2,800,984, and (2) acontinuation-in-part of International Application No. PCT/FR01/03258,filed on Oct. 19, 2001, which was published in a language other thanEnglish and which claimed priority from French Application No. 00/14028,filed on Oct. 31, 2000, now French Patent No. 2,815,844.

FIELD OF THE INVENTION

The present invention relates to a prosthetic cardiac valve and relateddeployment system that can be delivered percutaneously through thevasculature, and a method for delivering same.

BACKGROUND OF THE INVENTION

Currently, the replacement of a deficient cardiac valve is oftenperformed by opening the thorax, placing the patient underextracorporeal circulation, temporarily stopping the heart, surgicallyopening the heart, excising the deficient valve, and then implanting aprosthetic valve in its place. U.S. Pat. No. 4,106,129 to Carpentierdescribes a bioprosthetic heart valve with compliant orifice ring forsurgical implantation. This procedure generally requires prolongedpatient hospitalization, as well as extensive and often painfulrecovery. It also presents advanced complexities and significant costs.

To address the risks associated with open heart implantation, devicesand methods for replacing a cardiac valve by a less invasive means havebeen contemplated. For example, French Patent Application No. 99 14462illustrates a technique and a device for the ablation of a deficientheart valve by percutaneous route, with a peripheral valvular approach.International Application (PCT) Nos. WO 93/01768 and WO 97/28807, aswell as U.S. Pat. No. 5,814,097 to Sterman et al., U.S. Pat. No.5,370,685 to Stevens, and U.S. Pat. No. 5,545,214 to Stevens illustratetechniques that are not very invasive as well as instruments forimplementation of these techniques.

U.S. Pat. No. 3,671,979 to Moulopoulos and U.S. Pat. No. 4,056,854 toBoretos describe a catheter mounted artificial heart valve forimplantation in close proximity to a defective heart valve. Both ofthese prostheses are temporary in nature and require continuedconnection to the catheter for subsequent repositioning or removal ofthe valve prosthesis, or for subsequent valve activation.

With regard to the positioning of a replacement heart valve, attachingthis valve on a support with a structure in the form of a wire ornetwork of wires, currently called a stent, has been proposed. Thisstent support can be contracted radially in such a way that it can beintroduced into the body of the patient percutaneously by means of acatheter, and it can be deployed so as to be radially expanded once itis positioned at the desired target site. U.S. Pat. No. 3,657,744 toErsek discloses a cylindrical, stent-supported, tri-leaflet, tissue,heart valve that can be delivered through a portion of the vasculatureusing an elongate tool. The stent is mounted onto the expansion toolprior to delivery to the target location where the stent and valve isexpanded into place. More recently, U.S. Pat. No. 5,411,552 to Andersenalso illustrates a technique of this type. In the Andersen patent, astent-supported tissue valve is deliverable percutaneously to the nativeheart valve site for deployment using a balloon or other expandingdevice. Efforts have been made to develop a stent supported valve thatis self-expandable, using memory materials such as Nitinol.

The stent supported systems designed for the positioning of a heartvalve introduce uncertainties of varying degree with regard tominimizing migration from the target valve site. A cardiac valve that isnot adequately anchored in place to resist the forces of the constantlychanging vessel wall diameter, and turbulent blood flow therethrough,may dislodge itself, or otherwise become ineffective. In particular, theknown stents do not appear to be suited to sites in which the cardiacwall widens on either proximally and/or distally of the valve annulussitus. Furthermore, the native cardiac ring remaining after ablation ofthe native valve can hinder the positioning of these stents. These knownsystems also in certain cases create problems related to the sealingquality of the replacement valve. In effect, the existing cardiac ringcan have a surface that is to varying degrees irregular and calcified,which not only lessens the quality of the support of the stent againstthis ring but also acts as the source of leaks between the valve andthis ring. Also, these systems can no longer be moved at all afterdeployment of the support, even if their position is not optimal.

Also, the existing techniques are, however, considered not completelysatisfactory and capable of being improved. In particular, some of thesetechniques have the problem of involving, in any case, putting thepatient under extracorporeal circulation and temporarily stopping of theheart; they are difficult to put into practice; they do not allowprecise control of the diameter according to which the natural valve iscut, in view of the later calibration of the prosthetic valve; they leadto risks of diffusion of natural valve fragments, often calcified, intothe organism, which can lead to an embolism, as well as to risks ofperforation of the aortic or cardiac wall; they, moreover, induce risksof acute reflux of blood during ablation of the natural valve and risksof obstruction of blood flow during implantation of the device with aballoon expandable stent for example.

SUMMARY OF THE INVENTION

The object of the present invention is to transluminally provide aprosthetic valve assembly that includes features for preventingsubstantial migration of the prosthetic valve assembly once delivered toa desired location within a body. The present invention aims to remedythese significant problems. Another objective of the invention is toprovide a support at the time of positioning of the replacement valvethat makes it possible to eliminate the problem caused by the nativevalve sheets, which are naturally calcified, thickened and indurated, orby the residues of the valve sheets after valve resection. Yet anotherobjective of the invention is to provide a support making possiblecomplete sealing of the replacement valve, even in case of an existingcardiac ring which has a surface which is to varying degrees irregularand/or to varying degrees calcified. Another objective of the inventionis to have a device that can adapt itself to the local anatomy (i.e.varying diameters of the ring, the subannular zone, the sino-tubularjunction) and maintain a known diameter of the valve prosthesis tooptimize function and durability. The invention also has the objectiveof providing a support whose position can be adapted and/or corrected ifnecessary at the time of implantation.

The present invention is a prosthesis comprising a tissue valvesupported on a self-expandable stent in the form of a wire or aplurality of wires that can be contracted radially in order to makepossible the introduction of the support-valve assembly into the body ofthe patient by means of a catheter, and which can be deployed in orderto allow this structure to engage the wall of the site where the valveis to be deployed. In one embodiment, the valve is supported entirelywithin a central, self-expandable, band. The prosthetic valve assemblyalso includes proximal and distal anchors. In one embodiment, theanchors comprise discrete self-expandable bands connected to the centralband so that the entire assembly expands in unison into place to conformmore naturally to the anatomy. The valve can be made from a biologicalmaterial, such as an animal or human valve or tissue, or from asynthetic material, such as a polymer, and includes an annulus,leaflets, and commissure points. The valve is attached to the valvesupport band with, for example, a suture. The suture can be abiologically compatible thread, plastic, metal, or adhesive, such ascyanoacrylate.

In one embodiment, the valve support band is made from a single wirebent in a zigzag manner to form a cylinder. Alternatively, the valvesupport band can be made from a plurality of wires interwoven with oneanother. The wire can be made from stainless steel, silver, tantalum,gold, titanium, or any suitable tissue or biologically compatibleplastic, such as ePTFE or Teflon. The valve support band may have a loopat its ends so that the valve support band can be attached to an upperanchor band at its upper end, and a lower anchor band at its lower end.The link can be made from, for example, stainless steel, silver,tantalum, gold, titanium, any suitable plastic material, or suture.

The prosthetic valve assembly is compressible about its center axis suchthat its diameter can be decreased from an expanded position to acompressed position. The prosthetic valve assembly may be loaded onto acatheter in its compressed position, and so held in place. Once loadedonto the catheter and secured in the compressed position, the prostheticvalve assembly can be transluminally delivered to a desired locationwithin a body, such as a deficient valve within the heart. Once properlypositioned within the body, the catheter can be manipulated to releasethe prosthetic valve assembly and expand it into its expanded position.In one embodiment, the catheter includes adjustment hooks such that theprosthetic valve assembly may be partially released and expanded withinthe body and moved or otherwise adjusted to a final desired location. Atthe final desired location, the prosthetic valve assembly may be totallyreleased from the catheter and expanded to its fall expanded position.Once the prosthetic valve assembly is totally released from the catheterand expanded, the catheter may be removed from the body.

Other embodiments are contemplated. In one such alternative embodiment,this structure comprises an axial valve support portion, which has astructure in the form of a wire or in the form of a network of wiressuitable for receiving the replacement valve mounted on it, and suitablefor supporting the cardiac ring remaining after the removal of thedeficient native valve; at least one axial wedging portion, which has astructure in the form of a wire or in the form of a network of wiresthat is distinct from the structure of said axial valve support portion,and of which at least a part has, when deployed a diameter greater orsmaller than that of said deployed axial valve support portion, suchthat this axial wedging portion is suitable for supporting the wallbordering said existing cardiac ring; and at least a wire for connectingsaid portions, this wire or these wires being connected at points tothese portions in such a way as not to obstruct the deployment of saidaxial portions according to their respective diameters. The embodimentthus provides a support in the form of at least two axial portions thatare individualized with respect to one another with regard to theirstructure, which are connected in a localized manner by at least onewire; where this wire or these wires do not obstruct the variabledeployment of the axial portion with the valve and of the axial wedgingportion(s).

The presence of a structure in the form of a wire or in the form of anetwork of wires in the axial valve support portion makes possible aperfect assembly of this valve with this structure, and the shape aswell as the diameter of this axial portion can be adapted for supportingthe existing cardiac ring under the best conditions. In particular, thisaxial valve support portion can have a radial force of expansion suchthat it pushes back (“impacts”) the valve sheets that are naturallycalcified or the residues of the valve sheets after valve resection ontoor into the underlying tissues, so that these elements do not constitutea hindrance to the positioning of the replacement valve. This structurealso makes it possible to support possible anchoring means for thesupport and/or possible sealing means for the space existing between theexisting cardiac ring and the replacement valve, as indicated below.

The form and/or diameter of each axial wedging portion can be adaptedfor supporting the cardiac wall situated at the approach to the existingcardiac ring under the best conditions. In particular, this axialwedging portion can have a tubular shape with a constant diametergreater than that of the axial valve support portion, or the form of atruncated cone whose diameter increases with distance from the axialvalve support portion.

Preferably, the tubular support has an axial valve support portion inthe form of at least two parts, of which at least one is suitable forsupporting the valve and of which at least another is suitable forpushing back the native valve sheets or the residues of the native valvesheets after valve resection, into or onto the adjacent tissue in orderto make this region able to receive the tubular support. This axialvalve support portion eliminates the problem generated by these valve orcardiac ring elements at the time of positioning of the replacementvalve. The radial force of this axial valve support portion, byimpacting all or part of the valvular tissue or in the wall or itsvicinity in effect ensures a more regular surface more capable ofreceiving the valve support axis. It also ensures a better connectionwith the wall while reducing the risk of peri-prosthetic leakage.Furthermore, such a structure permits the valve to maintain a diameterwithin a preset range to ensure substantial coaptivity and avoidsignificant leakage.

Specifically, in order to support the valve, the axial valve supportportion can have a part in the form of an undulating wire withlarge-amplitude undulations, and a part in the form of an undulatingwire with small-amplitude undulations, adjacent to said part with largeamplitude undulations, having a relatively great radial force in orderto make it possible to push said valvular tissue against or into thewall of the passage. Preferably, the support according to one embodimentof the present invention has two axial wedging portions, one connectedto an axial end of said valve support portion and the other to the otheraxial end of this same valve support portion. These two axial wedgingportions thus make it possible to wedge the support on both sides of theexisting cardiac ring, and consequently make possible complete wedgingof the support in two opposite directions with respect to the treatedsite. If necessary, for example, in the case in which the passage withthe valve has an aneurysm, the support according to the invention has:an axial holding portion, suitable for supporting in the deployed statethe wall of the passage, and connecting wires such as the aforementionedconnecting wires, connecting said axial valve support portion and saidaxial holding portion, these wires having a length such that the axialholding portion is situated after implantation a distance away from theaxial valve support portion. This distance allows said axial holdingportion to rest against a region of the wall of the passage not relatedto a possible defect which may be present at the approach to the valve,particularly an aneurysm. The length of the connecting wires can also becalculated in order to prevent the axial holding portion from cominginto contact with the ostia of the coronary arteries. The aforementionedaxial portions (valve support, wedging, holding portions) can have astructure in the form of an undulating wire, in zigzag form, orpreferably a structure in diamond-shaped mesh form, the mesh parts beingjuxtaposed in the direction of the circumference of these portions. Thislast structure allows a suitable radial force making it possible toensure complete resting of said portions against the wall which receivesthem.

The support according to the invention can be produced from a metal thatcan be plastically deformed. The instrument for positioning of thesupport then includes a balloon which has an axial portion with apredetermined diameter, adapted for realizing the deployment of saidaxial valve support portion, and at least one axial portion shaped so asto have, in the inflated state, a greater cross section than that of thepassage to be treated, in such a way as to produce the expansion of theaxial wedging portion placed on it until this axial wedging portionencounters the wall which it is intended to engage. The supportaccording to this embodiment of the present invention can also beproduced from a material that can be elastically deformed or even amaterial with shape memory, such as the nickel-titanium alloy of thetype known as “Nitinol,” which can be contracted radially at atemperature different from that of the body of the patient and whichregains its original shape when its temperature approaches or reachesthat of the body of the patient.

According to another possibility, the support is produced from amaterial with shape memory but that can be plastically deformed, or hasparts made from a material with shape memory and parts made from amaterial that can be plastically deformed, and is formed in such a waythat it can be brought, by shape memory or plastic deformation, from astate of contraction to a stable intermediate state of deploymentbetween the state of contraction and the state of total deployment, andthen by plastic deformation or shape memory respectively, from saidintermediate state of deployment to said state of total deployment; insaid intermediate state of deployment, the support has dimensions suchthat it remains mobile with respect to the site to be treated. Thesupport is thus brought to the site to be treated and then is deployedfrom its intermediate state; its position can then possibly be adaptedand/or corrected, and then the support is brought to its state of totaldeployment. Specifically, the aforementioned material may have shapememory but that can be plastically deformed, such as a nickel-titaniumalloy of the type called “martensitic Nitinol” that can undergo plasticdeformation by means of a balloon.

Advantageously, the support according to the invention has someanchoring means suitable for insertion into the wall of the site to betreated, and is shaped in such a way as to be mobile between an inactiveposition, in which it does not obstruct the introduction of the supportinto the body of the patient, and an active position, in which it isinserted into the wall of the site to be treated. Substantially completeimmobilization of the support at the site is thus obtained. Inparticular, this anchoring means can be in the form of needles and canbe mounted on the support between retracted positions and radiallyprojected positions. Advantageously, the axial valve support portionhas, at the site of its exterior surface, a sealing means shaped in sucha way as to absorb the surface irregularities that might exist at ornear the existing cardiac ring. This sealing means can consist of aperipheral shell made from a compressible material such as polyester ortissue identical to the valve or a peripheral shell delimiting a chamberand having a radially expandable structure, this chamber being capableof receiving an inflating fluid suitable for solidifying after apredetermined delay following the introduction into said chamber. Thissealing means can also include a material that can be applied betweenthe existing cardiac ring and the axial valve support portion, thismaterial being capable of solidifying after a predetermined delayfollowing this application. Specifically, in this case, this material iscapable of heat activation, for example, by means of a laser, throughthe balloon, or capable of activation by emission of light ofpredetermined frequency, for example, by means of an ultraviolet laser,through the balloon. Said sealing means can also be present in the formof an inflatable insert with a spool-shaped cross section in theinflated state, which can be inserted between the existing cardiac ringand the axial valve support portion, Said spool shape allows this insertto conform to the best extent possible to the adjacent irregularstructures and to provide a better seal.

An assembly and method for removing the native valve is alsocontemplated. In particular, the invention has the objective ofproviding a device which gives complete satisfaction with regard to theexeresis and replacement of the valve, while allowing one to operatewithout opening of the thorax, stopping of the heart and/or opening ofthe heart, and preventing any diffusion into the circulatory system offragments of the removed valve. In one embodiment, the device comprises:an elongated support element; a first series of elongated bladesarranged around the circumference of said elongated element; theseblades are connected in a pivoting manner to the elongated element atthe site of their proximal longitudinal ends and each has a sharp edgeat the site of its distal longitudinal end; these blades can pivot withrespect to the elongated element between a folded up position, in whichthey are near the wall of the elongated element in such a way that theydo not stand in the way of the introduction and sliding of the device inthe body channel in which the valve is located, in particular in theaorta, and an opened out position, in which these blades are spread outin the form of a corolla in such a way that their sharp edges are placedin extension of one another and thus constitute a sharp circular edge; asecond series of blades, arranged consecutively to said first series ofblades in the distal direction; the blades of this second series ofblades have a structure identical to that of the blades of said firstseries of blades, except that these blades of this second series areconnected to the elongated element by their distal longitudinal ends andeach has a sharp edge at the site of its proximal longitudinal end;means making it possible to bring the blades of said first and secondseries of blades from their folded up position to their opened outposition; means making it possible to move said series of blades axiallyin the direction of one another, between a position of mutual distancingof these series of blades, in which one series of blades can be placedaxially on one side of the natural valve while the other series ofblades is placed axially on the other side of this valve, and a closetogether position, in which the sharp circular edges of these two seriesof blades are brought in mutual contact and thus cut off the naturalvalve, making it possible to position each of the two aforementionedseries of blades on one side of this valve.

The device according to the invention can be introduced percutaneouslyinto said body channel and can be slid in this channel until each of theaforementioned series of blades is placed on one side of the valve. Thisposition is identified using said means of identification. A system ofperipheral perfusion or extracorporeal circulation or a blood pumpthrough the center of the delivery system pumping blood from the leftventricle (proximal to the aortic valve) to the aorta (distal to theaortic valve) can be put in place in order to facilitate the flow of theblood, for the purpose of preventing stagnation of the blood in theheart. After the aforementioned positioning of the device, the blades ofthe two series of blades are spread out; then these two series arebrought closer together until the valve is cut off. The configuration ofthese blades makes it possible to execute this cutting in a singleoperation, therefore without generating fragments which can be diffusedinto the circulatory system, or at the very least generating only veryfew such fragments; this configuration moreover makes possible precisecontrol of the diameter according to which the natural valve is cut, inview of later calibration of the prosthetic valve. The blades are thenbrought back to the folded up position. The prosthetic valve is then putin place.

This valve can be separate from the device, in which case the latter isremoved and then the prosthetic valve is introduced and positioned insaid body channel by means of a separate device. Preferably however, thedevice according to the invention includes a proximal prosthetic valve,with a structure which can be spread out radially, with it possible forthis prosthetic valve to occupy a folded up position, in which it isnear the wall of said elongated element and does not sand in the way ofthe introduction and siding of the device in said body channel, and anopened out position, in which it rests against the wall of this channeland is capable of replacing the natural cardiac valve.

The device thus makes it possible to introduce and to position theprosthetic valve at the appropriate place in the body channel, by thesame action as that making it possible to cut off the natural valve.After cutting off of the latter, the device is slid axially in thedistal direction in order to bring the prosthetic valve to theappropriate site in this channel, after which this prosthetic valve isspread out. The device is then withdrawn, and the cut off natural valveis recovered.

Preferably, said elongated support element is a tubular catheter. Thiscatheter thus allows the blood to flow through it during the exeresis ofthe natural valve. The cross section of the channel of this catheter canbe sufficient to allow the blood to flow through this channel with orwithout the help of a pump, which limits or prevents resorting toputting the patient in extracorporeal circulation. The catheter can alsohave a small diameter, which facilitates the introduction and sliding ofthe device in the body channel, but it is then necessary to provideperipheral circulation by an external assistance system such as anextracorporeal circulation system. The catheter has a lateral distalopening in order to allow the blood to rejoin the body channel, forexample, the ascending aorta, this opening being arranged in such a waythat the length of catheter passed through the blood is as short aspossible.

Preferably, the device has a distal inflatable balloon, placed at thesite of the exterior surface of said elongated element; this balloon isconfigured so as to occupy a folded up position, in which it has a crosssection such that it does not stand in the way of the introduction andto the sliding of the device in said body channel, and an opened outposition, in which it occupies the whole space existing between theexterior surface of said elongated element and the wall of said bodychannel and rests, by a peripheral edge which it has, against this wall.The balloon is inflated after the positioning of the series of blades onboth sides of the natural valve, in order to prevent reflux of the bloodduring the ablation of the natural valve. If said elongated element is acatheter, this balloon moreover makes it possible to case this blood toflow only through the catheter. Once the prosthetic valve is positioned,the balloon is brought back to a folded up position so as tore-establish the blood flow through the body channel.

Preferably, the device has a distal filter made of flexible material,placed in the site of the exterior surface of said elongated element;this filter is configured so that it can occupy a folded up position, inwhich it has a cross section such that it does not stand in the way ofthe introduction and sliding of the device in said body channel, and anopened out position, in which it occupies the whole space existingbetween the exterior surface of said elongated element and the wall ofthe channel and rests, by a peripheral edge which it has, against thiswall. This filter makes it possible to catch possible fragmentsgenerated by the exeresis of the valve and to retain them so that theyare removed from the blood circulation. The device can have some meansmaking it possible to move said series of blades in the axial directionindependently from said balloon and/or from said filter. Once openedout, this or these means do not have to be moved axially in the bodychannel during the aforementioned axial movement of the series ofblades.

Said balloon and/or said filter can also be separate from the device,being mounted on an elongated support element which belongs to them. Incase of operation on a mitral valve, this balloon and/or this filteris/are introduced into the aorta by a peripheral artery route, and thedevice is itself introduced into the heart by the peripheral venoussystem, up to the right atrium and then into the left atrium through theinteratrial septum, up to the site of the mitral valve. The prostheticvalve can advantageously have a frame made of a material with a shapememory, particularly a nickel-titanium alloy known as “Nitinol.” Thissame valve can have valves made of biological material (preserved animalor human valves) or valves made of synthetic material such as a polymer.When replacing an aortic valve the device may be alternativelyintroduced in a retrograde manner through a peripheral artery (femoralartery) or through a venous approach and trans-septally (antegrade).

The above embodiments and methods of use are explained in more detailbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional side view of one embodiment of an assemblyof the present invention for removing and replacing a native heart valvepercutaneously;

FIG. 2 is a cross-section axial view of the assembly of FIG. 1 taken atline II-II, shown in a closed condition;

FIG. 3 is a cross-section axial view of the assembly of FIG. 1 taken atline II-II, shown in an opened condition;

FIG. 4 is a perspective schematic View of one embodiment of a prostheticvalve of the present invention;

FIGS. 5 to 9 are schematic views of the assembly of the presentinvention positioned in a heart, at the site of the valve that is to betreated, during the various successive operations by means of which thisvalve is cut out and the prosthetic valve shown in FIG. 4 deployed;

FIG. 10 is a schematic view of the prosthetic valve shown of FIG. 4shown in a deployed state;

FIG. 11 is a schematic view of an alternative embodiment of the assemblyof the present invention shown treating a mitral valve;

FIG. 12 is a cross-sectional view of a section of a blade used inexcising the native valve;

FIG. 13 is a schematic view of one embodiment of the support structureof the prosthesis assembly of the present invention;

FIG. 14 is a cross-sectional view of the support of FIG. 13 showing aheart valve supported by the central portion of the support;

FIG. 15 is an end view of the support of FIGS. 13 and 14 in the deployedstate;

FIG. 16 is an end view of the support of FIGS. 13 and 14 in thecontracted state;

FIG. 17 is a schematic view of a heart with an embodiment of the presentinventive prosthesis shown deployed in place;

FIG. 18 is a schematic view of an alternative embodiment of the presentinvention;

FIG. 19 is schematic view of an alternative embodiment of the presentinvention;

FIG. 20 is a detail view of a part of the support structure of oneembodiment of the present invention;

FIG. 21 is a schematic view of the support of FIG. 19 shown in adeployed state;

FIG. 22 is schematic view of an alternative embodiment of the presentinvention;

FIG. 23 is a detail view of the support of FIG. 22 shown in thecontracted state;

FIG. 24 is a detail view of the support of FIG. 23 taken along line23-23;

FIG. 25 is a detail view of the support of FIG. 22 shown in the expandedstate;

FIG. 26 is a detail view of the support of FIG. 25 taken along line25-25;

FIG. 27 is a schematic view of an alternative embodiment of the presentinvention;

FIG. 28 is a detailed cross section view of the support of FIG. 27;

FIG. 29 is a partial schematic view in longitudinal section of thesupport of the present invention and of a calcified cardiac ring;

FIG. 30 is a schematic view of an alternative to the support of FIG. 29;

FIG. 31 is a schematic view of an alternative to the support of FIG. 29;

FIGS. 32 and 33 are schematic views of an alternative to the support ofFIG. 29;

FIG. 34 is a schematic cross-sectional view of a balloon correspondingto the support structure of FIGS. 19 to 21;

FIG. 35 is a schematic longitudinal sectional view of an alternativeembodiment of the balloon of FIG. 34;

FIG. 36 is a schematic view of a heart with an embodiment of the presentinventive prosthesis shown deployed in place;

FIG. 37 is a perspective view of one embodiment of a prosthetic valveassembly of the present invention;

FIG. 38 is a side view of the prosthetic valve assembly of FIG. 37;

FIG. 39 is a photograph of one embodiment of the prosthetic valveassembly of FIG. 37;

FIG. 40 is a photograph of an alternative, embodiment of the prostheticvalve assembly with a sheath around the valve;

FIG. 41A is a perspective view of a distal portion of a catheterassembly for use in deploying the prosthetic valve assembly describedherein;

FIG. 41B is a perspective view of a proximal portion of the catheterassembly of FIG. 41A;

FIG. 42 is a photograph of the distal portion of the catheter assemblyof FIG. 41A;

FIGS. 43 through 45 are photographs of the catheter assembly of FIG. 40Ashowing deployment of a prosthesis assembly in sequence;

FIGS. 46 and 47 are photographs of the catheter assembly of FIG. 41Ashowing deployment of an alternative prosthesis assembly;

FIG. 48 is a photograph of the alternative prosthesis assembly shown inFIGS. 46 and 47; and

FIG. 49 is a photograph of an alternative embodiment of the prostheticvalve assembly of FIG. 37 showing only a distal anchor.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Reference is now made to the figures wherein like parts are designatedwith like numerals throughout. FIGS. 1 to 3 represent a device 1 forreplacing a heart valve by a percutaneous route. This device comprises atubular catheter 2 formed from three tubes 5, 6, 7 engaged one insidethe other and on which there are placed, from the proximal end to thedistal end (considered with respect to the flow of blood, that is to sayfrom right to left in FIG. 1), a prosthetic valve 10, two series ofblades 11, 12, a balloon 13 and a filter 14. The three tubes 5, 6, 7 aremounted so that they can slide one inside the other. The interior tube 5delimits a passage 15, the cross section of which is large enough toallow blood to flow through it. At the proximal end, the intermediatetube 6 forms a bell housing 6 a delimiting, with the interior tube 5, anannular cavity 17 in which the prosthetic valve 10 is contained in thefurled condition.

FIG. 4 shows that this valve 10 comprises an armature 20 and valveleaflets 21 mounted so that they are functionally mobile on thisarmature 20. The armature consists of a collection of wires 22, 23, 24made of shape memory material, particularly of nickel-titanium alloyknown by the name of “NITINOL;” namely, (i) a proximal end wire 22which, when the valve 10 is in the deployed state, has a roughlycircular shape; (ii) a distal end wire 23 forming three corrugations inthe axial direction, these corrugations being distributed uniformlyaround the circumference of the valve 10, and (iii) an intermediate wire24 forming longitudinal corrugations between the wires 22 and 23, thiswire 24 being connected to the latter ones via the ends of each of thesecorrugations. The valve leaflets 21 for their part are made ofbiological material (preserved human or animal valve leaflets) or ofsynthetic material, such as a polymer. The armature 20 may, when itsmaterial is cooled, be radially contracted so that the valve 10 canenter the cavity 17. When this material is heated to body temperature,this armature 20 returns to its original shape, depicted in FIG. 4, inwhich it has a diameter matched to that of a bodily vessel, particularlythe aorta, in which the native valve that is to be treated lies. Thisdiameter of the armature 20 is such that the valve 10 bears against thewall of the bodily vessel and is immobilized in the axial direction withrespect to that vessel.

Each series of blades 11, 12 comprises metal elongate blades 30 and aninflatable balloon 31 situated between the catheter 2 and these blades30. The blades 30 have a curved profile and are arranged on thecircumference of the catheter 2, as shown in FIGS. 2 and 3. The blades30 of the proximal series 11 are connected pivotably to the tube 6 bytheir proximal ends and comprise a cutting distal edge 30 a, while theblades 30 of the distal series 12 are connected pivotably to theexterior tube 7 by their distal ends and comprise a cutting proximaledge 30 b. The connection between the blades 30 and the respective tubes6 and 7 is achieved by welding the ends of the blades 30 together toform a ring, this ring being fixed axially to the corresponding tube 6,7 by crimping this ring onto this tube 6, 7, the pivoting of the blades30 being achieved by simple elastic deformation of these blades 30. Thispivoting can take place between a position in which the blades 30 arefurled, radially internally with respect to the catheter 2 and shown inFIGS. 1 and 2, and a position in which these blades 30 are unfurled,radially externally with respect to this catheter 2 and shown in FIG. 3.In the furled position, the blades 30 lie close to the wall of the tube6 and partially overlap each other so that they do not impede theintroduction and the sliding of the device 1 into and in the bodilyvessel in which the native valve that is to be treated lies; in saidunfurled position, the blades 30 are deployed in a corolla so that theircutting edges 30 a, 30 b are placed in the continuation of one anotherand thus constitute a circular cutting edge visible in FIG. 3.

Each balloon 31, placed between the tube 3 and the blades 30, may beinflated from the end of the catheter 2 which emerges from the patient,via a passage 32 formed in the tube 6. It thus, when inflated, allowsthe blades 30 to be brought from their furled position into theirunfurled position, and performs the reverse effect when deflated. Theaxial sliding of the tube 6 with respect to the tube 7 allows the seriesof blades 11, 12 to be moved axially toward one another, between aspaced-apart position shown in FIG. 1, and a close-together position. Inthe former of these positions, one series of blades 11 may be placedaxially on one side of the native valve while the other series of blades12 is placed axially on the other side of this valve, whereas in thelatter of these positions, the circular cutting edges of these twoseries of blades 11, 12 are brought into mutual contact and thus cutthrough the native valve in such a way as to detach it from said bodilyvessel. The tabes 5 to 7 further comprise marks (not visible in thefigures) in barium sulfate allowing the axial position of the device 1with respect to the native valve to be identified percutaneously so thateach of the two series of blades 11, 12 can be placed on one axial sideof this valve. These tubes 5 to 7 also comprise lateral distal openings(not depicted) to allow the blood to reach the bodily vessel, theseopenings being formed in such a way that the length of catheter 2through which the blood flows is as short as possible, that is to sayimmediately after the filter 14, in the distal direction.

The balloon 13 is placed on the exterior face of the tube 7, distallywith respect to the series 12. This balloon 13 has an annular shape andis shaped to be able to occupy a furled position in which it has a crosssection such that it does not impede the introduction and sliding of thedevice 1 into and in said bodily vessel, and an unfurled position, inwhich it occupies all of the space between the exterior face of the tube7 and the wall of said bodily vessel and, via a peripheral edge 13 awhich it comprises, hears against this wall.

The filter 14 is placed distally with respect to the balloon 13, on thetube 7, to which it is axially fixed. This filter 14 is made of flexiblematerial, for example polyester netting, and is shaped to be able tooccupy a furled position in which it has a cross section such that itdoes not impede the introduction and sliding of the device 1 into and insaid bodily vessel, and an unfurled position in which it occupies all ofthe space between the exterior face of the catheter 2 and the wall ofthis vessel and, via a peripheral edge 14 a which it comprises, bearsagainst this wall.

An inflatable balloon 35 is placed between the tube 7 and the filter 14so as, depending on whether it is inflated or deflated, to bring thefilter 14 into its respective unfurled and furled positions. Inpractice, as shown by FIGS. 5 to 9, the device 1 is introduced into saidbodily vessel 50 by a percutaneous route and is slid along inside thisvessel 50 until each of the series 11, 12 of blades is placed on oneside of the native valve 55 that is to be treated (FIG. 5). Thisposition is identified using the aforementioned marks. When the deviceis in this position, the proximal part of the catheter 2 is situated inthe heart, preferably in the left ventricle, while the aforementioneddistal lateral openings are placed in a peripheral arterial vessel,preferably in the ascending aorta. The balloons 13 and 35 are inflatedin such a way as to cause blood to flow only through the passage 15 andprevent blood reflux during the ablation of the valve 55. A peripheralperfusion system is set in place to facilitate this flow. The blades 30of the two series 11, 12 are then deployed (FIG. 6) by inflating theballoons 31, then these two series 11, 12 are moved closer together bysliding the tube 6 with respect to the tube 7, until the valve 55 is cutthrough (FIG. 7). The blades 30 are then returned to their furledposition by deflating the balloons 31 while at the same time remainingin their close-together position, which allows the cut-out valve 55 tobe held between them. The device 1 is then slid axially in the distaldirection so as to bring the bell housing 6 a to the appropriateposition in the vessel 50 (FIG. 8), after which the valve 10 is deployedby sliding the tube 6 with respect to the tube 5 (FIG. 9). The balloons13 and 35 are deflated then the device 1 is withdrawn and the cut-outvalve 55 is recovered (FIG. 10).

FIG. 11 shows a second embodiment of the device 1, allowing operation ona mitral valve 56. The same reference numerals are used to denote thesame elements or parts as the aforementioned, as long as these elementsor parts are identical or similar in both embodiments. In this case, thetubular catheter is replaced by a support wire 2, on which one of theseries of blades is mounted and by a tube engaged over and able to slidealong this wire, on which tube the other series of blades is mounted;the passages for inflating the balloons 31 run along this support wireand this tube; the balloon 13 and the filter 14 are separate from thedevice 1 and are introduced into the aorta via a peripheral arterialroute, by means of a support wire 40 along which the passages forinflating the balloons 13 and 35 run. The device 1, devoid of balloon 13and the filter 14, is for its part introduced into the heart through theperipheral venous system, as far as the right atrium then into the leftatrium through the inter-auricular septum, as far as the valve 56. Forthe remainder, the device 1 operates in the same way as was mentionedearlier. The invention thus provides a device for replacing a heartvalve by a percutaneous route, making it possible to overcome thedrawbacks of the prior techniques. Indeed the device 1 is entirelysatisfactory as regards the cutting-away of the valve 55, 56, making itpossible to operate without stopping the heart and making it possible,by virtue of the filter 14, to prevent any dispersion of valve fragments55, 56 into the circulatory system.

The above device may comprise a fourth tube, engaged on and able toslide along the tube 7, this fourth tube comprising the balloon and thefilter mounted on it and allowing said series of blades to be moved inthe axial direction independently of said balloon and/or of said filter;the blades may be straight as depicted in the drawing or may be curvedtoward the axis of the device at their end which has the cutting edge,so as to eliminate any risk of lesion in the wall of the bodily vessel,as shown in FIG. 12; the filter 14 may be of the self-expanding type andnormally kept in the contracted position by a sliding tube, which coversit, making the balloon 35 unnecessary.

FIGS. 13 to 16 represent tubular support 101 for positioning, bypercutaneous route, of replacement heart valve 102. The supportstructure 101 includes median portion 103, which contains valve 102, twoextreme wedging portions 104 and wires 105 for connecting these portions103 and 104, Median portion 103 also includes peripheral shell 106provided with anchoring needles 107 and shell 108 made of compressiblematerial. As is particularly apparent from FIG. 13, each of portions 103and 104 is formed with an undulating wire, and wires 105 connectpointwise the ends of the undulations of portion 103 to the end of anadjacent wave of portion 104. Portions 104, seen in expanded form, havelengths greater than the length of portion 103, so that when the ends ofthe wires respectively forming portions 103 and 104 are connected inorder to form the tubular support structure 101, the diameter of portion103 is smaller than the diameter of portions 104.

The diameter of portion 103 is such that portion 103 can, as shown byFIG. 17, support cardiac ring 110 that remains after removal of thedeficient native valve, while portions 104 cart support walls 111bordering ring 110. These respective diameters are preferably such thatsaid supporting operations take place with slight radial restraint ofring 110 and walls 111. Portion 103 presents in the deployed state aconstant diameter. Portions 104 can have a constant diameter in the formof a truncated cone whose diameter increases away from portion 103. Theentire support structure 101 can be made from a material with shapememory, such as the nickel-titanium alloy known as “Nitinol.” Thismaterial allows the structure to be contracted radially, as shown inFIG. 16, at a temperature different form that of the body of the patientand to regain the original shape shown in FIGS. 14 and 15 when itstemperature approaches or reaches that of the body of the patient. Theentire support structure 101 can also be made from a material that canbe expanded using a balloon, such as from medical stainless steel (steel316 L). Valve 102 can be made of biological or synthetic tissue. It isconnected to portion 103 by sutures or by any other appropriate means ofattachment. It can also be molded on portion 103. Shell 106 may be madeof “Nitinol.” It is connected to the undulations of portion 103 atmid-amplitude, and has needles 107 at the site of its regions connectedto these undulations. Needles 107 consist of strands of metallic wirepointed at their free ends, which project radially towards the exteriorof shell 106.

This shell can take on the undulating form which can be seen in FIG. 16in the contracted state of support 101 and the circular form which canbe seen in FIG. 4 in the deployed state of this support 101. In itsundulating form, shell 106 forms undulations 106 a projecting radiallyon the outside of support 101, beyond needles 107, so that these needles107, in the retracted position, do not obstruct the introduction ofsupport 101 in a catheter or, once support 101 has been introduced intothe heart using this catheter, do not obstruct the deployment out ofthis support 1. The return of shell 6 to its circular form bringsneedles 107 to a position of deployment, allowing them to be inserted inring 110 in order to complete the anchoring of support 101. Shell 108 isattached on shell 106. Its compressible material allows it to absorb thesurface irregularities which might exist at or near ring 110 and thus toensure complete sealing of valve 102.

FIG. 18 shows a support structure 101 having a single portion 104connected to portion 103 by wires 105. This portion 104 is formed by twoundulating wires 114 connected together by wires 115. FIG. 19 shows asupport structure 101 which has portion 103 and portion 104 connected byconnecting wires 105. These portions 103 and 104 have diamond-shapedmesh structures, these mesh parts being juxtaposed in the direction ofthe circumference of these portions and connected together at the siteof two of their opposite angles in the direction of the circumference ofthese portions 103 and 104. Wires 105 are connected to these structuresat the site of the region of junction of two consecutive mesh parts.These mesh parts also have anchoring hooks 107 extending through themfrom one of their angles situated in the longitudinal direction ofsupport 101.

FIG. 20 illustrates, in an enlarged scale, the structure of this portion104 and of a part of wires 105, as cut, for example, with a laser from acylinder of stainless steel, and after bending of sharp ends 107 a ofhooks 107. These hooks, in a profile view, can have the shape as shownin FIG. 24 or 26. The structure represented in FIG. 19 also has axialholding portion 120, which has a structure identical to that of portion104 but with a coarser mesh size, and three wires 105 of significantlength connecting this portion 120 to portion 103. These wires 105, onthe side of portion 120, have a single link 105 a and on the side ofportion 103, a double link 105 b. Their number corresponds to the threejunctions formed by the three valves of valve 102, which facilitatesmounting of valve 102 on support 101 thus formed. The support accordingto FIG. 19 is intended to be used, as appears in FIG. 21, when the bodypassage with the valve to be replaced, in particular the aorta, has avariation in diameter at the approach to the valve. The length of wires105 connecting portions 103 and 120 is provided so that afterimplantation, portion 120 is situated in a non-dilated region of saidbody passage, and this portion 120 is provided so as to engage the wallof the passage.

FIG. 22 shows a structure similar to that of FIG. 19 but unexpanded,except that the three wires 105 have a single wire structure but have anundulating wire 121 ensuring additional support near portion 103. Thiswire 121 is designed to support valve 102 with three valve leaflets.FIGS. 23 to 26 show an embodiment variant of the structure of portions103, 104 or 120, when this structure is equipped with hooks 107. In thiscase, the structure has a zigzagged form, and each hook 107 has two arms107 b; each of these arms 107 b is connected to the other arm 107 b atone end and to an arm of structure 101 at its other end. The region ofjunction of the two arms 107 b has bent hooking pin 107 a.

FIG. 27 shows portion 103 which has two undulating wires 125, 126extending in the vicinity of one another and secondary undulating wire127. As represented in FIG. 28, wires 125, 126 can be used to executethe insertion of valve 102 made of biological material between them andthe attachment of this valve 102 to them by means of sutures 127. FIG.29 shows a part of support 101 according to FIGS. 13 to 17 and the wayin which the compressible material constituting shell 108 can absorb thesurface irregularities possibly existing at or near ring 110, whichresult from calcifications. FIG. 30 shows support 101 whose shell 106has no compressible shell. A material can then be applied, by means ofan appropriate cannula (not represented), between ring 110 and thisshell 106, this material being able to solidify after a predetermineddelay following application.

FIG. 31 shows support 101 whose shell 106 has a cross section in theform of a broken line, delimiting, on the exterior radial side, a lowershoulder. Housed in the step formed by this shoulder and the adjacentcircumferential wall is peripheral shell 108 which can be inflated bymeans of a catheter (not represented). This shell 108 delimits a chamberand has a radially expandable structure, such that it has in crosssection, in the inflated state, two widened ends projecting on bothsides of shell 106. This chamber can receive an inflating fluid that cansolidify in a predetermined delay following its introduction into saidchamber. Once this material has solidified, the inflating catheter iscut off.

FIGS. 32 and 33 show support 101 whose shell 106 receives inflatableinsert 108 which has a spool-shaped cross section in the inflated state;this insert 108 can be inflated by means of catheter 129. Insert 108 ispositioned in the uninflated state (FIG. 32) at the sites in which aspace exists between shell 106 and existing cardiac ring 110. Its spoolshape allows this insert (cf. FIG. 33) to conform as much as possible tothe adjacent irregular structures and to ensure a better seal.

FIG. 34 shows balloon 130 making it possible to deploy support 101according to FIGS. 19 to 21. This balloon 130 has cylindrical portion131 whose diameter in the inflated state makes possible the expansion ofholding portion 120, a cylindrical portion 132 of lesser diameter,suitable for producing the expansion of portion 103, and portion 133 inthe form of a truncated cone, makes possible the expansion of portion104. As shown by FIG. 35, portion 132 can be limited to what is strictlynecessary for deploying portion 103, which makes it possible to produceballoon 130 in two parts instead of a single part, thus limiting thevolume of this balloon 130.

FIG. 36 shows support 101 whose median portion 103 is in two parts 103a, 103 b. Part 103 a is made of undulating wire with large-amplitudeundulations, in order to support valve 102, and part 103 b, adjacent tosaid part 103 a and connected to it by bridges 135, is made ofundulating wire with small-amplitude undulations. Due to its structure,this part 103 b presents a relatively high radial force of expansion andis intended to be placed opposite ring 110 in order to push back: thenative valve sheets which are naturally calcified, thickened andindurated, or the residues of the valve sheets after valve resectionagainst or into the wall of the passage. This axial portion 103 a, 103 bthus eliminates the problem induced by these sheets or residual sheetsat the time of positioning of valve 102.

It is apparent from the preceding that one embodiment of the inventionprovides a tubular support for positioning, by percutaneous route, of areplacement heart valve, which provides, due to its portions 103 and104, complete certitude as to its maintenance of position afterimplantation. This support also makes possible a complete sealing of thereplacement valve, even in case of a cardiac ring with a surface that isto varying degrees irregular and/or calcified, and its position can beadapted and/or corrected as necessary at the time of implantation.

Referring to FIGS. 37 and 38, the present invention also comprises analternative prosthetic valve assembly 310, which further comprises aprosthetic valve 312, a valve support band 314, distal anchor 316, and aproximal anchor 318. Valve 312 can be made from a biological material,such as one originating from an animal or human, or from a syntheticmaterial, such as a polymer. Depending upon the native valve to bereplaced, the prosthetic valve 312 comprises an annulus 322, a pluralityof leaflets 324, and a plurality of commissure points 326. The leaflets324 permit the flow of blood through the valve 312 in only onedirection. In the preferred embodiment, the valve annulus 322 and thecommissure points 326 are all entirely supported within the centralsupport band 314. Valve 312 is attached to the valve support band 314with a plurality of sutures 328, which can be a biologically compatiblethread. The valve could also be supported on band 314 with adhesive,such as cyanoacrylate.

In one embodiment, valve 312 can be attached to, or may integral with, asleeve or sheath (not shown). The sheath is secured to the valve supportband 314 such that the outer surface of the sheath is substantially incontact with the inner surface of the valve support band 314. In suchembodiment, the sheath can be attached to the valve support band 314with sutures 328. FIG. 40 is a photograph of the concept of thisalternative embodiment. If desired, the sheath can be secured to theoutside of valve support band 314 (not shown).

Referring to FIGS. 37 and 38, in one embodiment, valve support band 314is made from a single wire 342 configured in a zigzag manner to form acylinder. Alternatively, valve support band 314 can be made from aplurality of wires 342 attached to one another. In either case, the bandmay comprise one or more tiers, each of which may comprise one or morewires arranged in a zigzag manner, for structural stability ormanufacturing ease, or as anatomical constraints may dictate. Ifdesired, even where the central valve support 314 is manufactured havingmore than one tier, the entire valve support 314 may comprise a singlewire. Wire 342 can be made from, for example, stainless steel, silver,tantalum, gold, titanium, or any suitable plastic material. Valvesupport band 314 may comprise a plurality of loops 344 at opposing endsto permit attachment to valve support band 314 of anchors 316 and/or 318with a link. Loops 344 can be formed by twisting or bending the wire 342into a circular shape. Alternatively, valve support band 314 and loops344 can be formed from a single wire 342 bent in a zigzag manner, andtwisted or bent into a circular shape at each bend. The links can bemade from, for example, stainless steel, silver, tantalum, gold,titanium, any suitable plastic material, solder, thread, or suture. Theends of wire 342 can be joined together by any suitable method,including welding, gluing or crimping.

Still referring to FIGS. 37 and 38, in one embodiment, distal anchor 316and proximal anchor 318 each comprise a discrete expandable band madefrom one or more wires 342 bent in a zigzag manner similar to thecentral band. Distal anchor band 316 and proximal anchor band 318 maycomprise a plurality of loops 344 located at an end of wire 342 so thatdistal anchor band 316 and proximal anchor band 318 can each be attachedto valve support band 314 with a link. Loop 344 can be formed bytwisting or bending the wire 342 into a circular shape. As desired,distal and/or proximal anchors 316, 318 may comprise one or more tiers,as explained before with the valve support 314. Likewise, each anchormay comprise one or more wires, regardless of the number of tiers. Asexplained above in regard to other embodiments, the distal anchor may beattached to the central valve support band 314 directly, as in FIG. 37,or spaced distally from the distal end of the valve support 314, asshown above schematically in FIGS. 18, 19,21 and 22. In the laterinstance, one or more struts may be used to link the distal anchor bandto the valve support band, as described above.

Distal anchor band 316 has a first end 350 attached to the central valveband 314, and a second end 352. Similarly, proximal anchor band 318 hasfirst attached end 354 and a second end 356. The unattached ends 352,356 of the anchors 316, 318, respectively are free to expand in a flaredmanner to conform to the local anatomy. In such embodiment the distaland proximal anchor bands 316, 318 are configured to exert sufficientradial force against the inside wall of a vessel in which it can beinserted. Applying such radial forces provides mechanical fixation ofthe prosthetic valve assembly 310, reducing migration of the prostheticvalve assembly 310 once deployed. It is contemplated, however, that theradial forces exerted by the valve support 314 may be sufficient toresist more than a minimal amount of migration, thus avoiding the needfor any type of anchor.

In an alternative embodiment, distal and proximal anchors may comprise afixation device, including barbs, hooks, or pins (not shown). Suchdevices may alternatively or in addition be placed on the valve support314. If so desired, the prosthetic valve assembly 310 may comprise anadhesive on the exterior thereof to adhere to the internal anatomicallumen.

Prosthetic valve assembly 310 is compressible about its center axis suchthat its diameter may be decreased from an expanded position to acompressed position. When placed into the compressed position, valveassembly 310 may be loaded onto a catheter and transluminally deliveredto a desired location within a body, such as a blood vessel, or adefective, native heart valve. Once properly positioned within the bodythe valve assembly 310 can be deployed from the compressed position tothe expanded position. FIG. 39 is a photograph of one embodiment of theprosthetic valve assembly described with both distal and proximal anchorbands while FIG. 49 is a photograph showing only a distal anchor.

In the preferred embodiment, the prosthetic valve assembly 310 is madeof self-expanding material, such as Nitinol. In an alternativeembodiment, the valve assembly 310 requires active expansion to deployit into place. Active expansion may be provided by an expansion devicesuch as a balloon.

As referred to above in association with other embodiments, theprosthetic valve assembly of the present invention is intended to bepercutaneously inserted and deployed using a catheter assembly.Referring to FIG. 41A, the catheter assembly 510 comprises an outersheath 512, an elongate pusher tube 514, and a central tube 518, each ofwhich are concentrically aligned and permit relative movement withrespect to each other. At a distal end of the pusher tube 514 is apusher tip 520 and one or more deployment hooks 522 for retaining theprosthesis assembly (not shown). The pusher tip 520 is sufficientlylarge so that a contracted prosthesis assembly engages the pusher tip520 in a frictional fit arrangement. Advancement of the pusher tube 514(within the outer sheath 512) in a distal direction serves to advancethe prosthesis relative to the outer sheath 512 for deployment purposes.

At a distal end of the central tube 518 is an atraumatic tip 524 forfacilitating the advancement of the catheter assembly 510 through thepatient's skin and vasculature. The central tube 518 comprises a centrallumen (shown in phantom) that can accommodate a guide wire 528. In oneembodiment, the central lumen is sufficiently large to accommodate aguide wire 528 that is 0.038 inch in diameter. The guide wire can slidethrough the total length of the catheter form tip to handle (‘over thewire’ catheter) or the outer sheath 512 can be conformed so as to allowfor the guide wire to leave the catheter before reaching its proximalend (‘rapid exchange’ catheter). The space between the pusher tube 514and the outer sheath 512 forms a space within which a prosthetic valveassembly may be mounted.

Hooks 522 on the distal end of the pusher tube 514 may be configured inany desired arrangement, depending upon the specific features of theprosthetic assembly. With regard to the prosthesis assembly of FIGS. 37and 38, the hooks 522 preferably comprise an L-shaped arrangement toretain the prosthesis assembly axially, but not radially. With aself-expanding assembly, as the prosthesis assembly is advanced distallybeyond the distal end of the outer sheath 512, the exposed portions ofthe prosthesis assembly expand while the hooks 522 still retain theportion of the prosthesis still housed within the outer sheath. When theentire prosthesis assembly is advanced beyond the distal end of theouter sheath, the entire prosthesis assembly is permitted to expand,releasing the assembly from the hooks. FIGS. 42 through 45 show thedistal end of one embodiment of the catheter assembly, three of whichshow sequenced deployment of a valve prosthesis.

In an alternative embodiment of the valve prosthesis, loop elementsextend axially from one end of the prosthesis, where the loop elementscan be retained by the hooks 522 during deployment. This alternativeembodiment is shown in the photograph of FIG. 48, where the photographsof FIGS. 46 and 47 show a catheter assembly used for deploying thealternative prosthesis assembly. By adding loop elements to theprosthesis, the prosthesis may be positioned with its support andanchors fully expanded in place while permitting axial adjustment intofinal placement before releasing the prosthesis entirely from thecatheter.

FIG. 41B shows the proximal end of the catheter assembly 510, which to agreater extent has many conventional features. At the distal end of thepusher tube 514 is a plunger 530 for advancing and retreating the pushertube 514 as deployment of the prosthesis assembly is desired. Asdesired, valves and flush ports proximal and distal to the valveprosthesis may be provided to permit effective and safe utilization ofthe catheter assembly 510 to deploy a prosthesis assembly.

In one embodiment, prosthetic valve assembly 310 (not shown) is mountedonto catheter 510 so that the valve assembly 310 may be delivered to adesired location inside of a body. In such embodiment, prosthetic valveassembly 310 is placed around pusher tip 520 and compressed radiallyaround the tip 520. The distal end of prosthetic valve assembly 310 ispositioned on the hooks 522. While in the compressed position, outersheath 512 is slid toward the atraumatic tip 524 until it substantiallycovers prosthetic valve assembly 310.

To deliver prosthetic valve assembly 310 to a desired location withinthe body, a guide wire 528 is inserted into a suitable lumen of thebody, such as the femoral artery or vein to the right atrium, then tothe left atrium through a transseptal approach, and maneuvered,utilizing conventional techniques, until the distal end of the guidewire 528 reaches the desired location. The catheter assembly 510 isinserted into the body over the guide wire 528 to the desired position.Atraumatic tip 524 facilitates advancement of the catheter assembly 510into the body. Once the desired location is reached, the outer sheath512 is retracted permitting the valve prosthesis to be released fromwithin the outer sheath 512, and expand to conform to the anatomy. Inthis partially released state, the position of prosthetic valve 310 maybe axially adjusted by moving catheter assembly 510 in the proximal ordistal direction.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrative,and not restrictive and the scope of the invention is, therefore,indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A prosthetic device for replacing a deficientnative aortic valve, the valve assembly comprising: a collapsible andexpandable annular support stent formed of a shape memory alloy andhaving a circular outer profile, the support stent comprising; a firstportion configured to expand to a first expanded diameter, a secondportion configured to expand to a second expanded diameter, the secondportion being downstream from the first portion, the second expandeddiameter being substantially larger than the first expanded diameter,and a central portion between the first and second portions, the centralportion configured to expand to a third diameter sized to provide aradial gap between the support stent and the inner wall of the ascendingaorta at the level of the openings of the coronary arteries; and acollapsible and expandable valve assembly formed of biological material,the valve assembly located entirely within an interior portion of thesupport stent, the valve assembly having three valve leaflets and threecommissural points sutured to the support stent for supporting the threevalve leaflets; wherein the first portion of the support stent isconfigured to contact the leaflets of the native aortic valve, thesecond portion of the support stent is configured to contact the innerwall of the ascending aorta at a location above the openings of thecoronary arteries, and the support stent is formed with an open wallstructure downstream of the valve assembly for allowing blood to passthrough a wall of the support stent from the interior portion of thesupport stent to the openings of the coronary arteries.
 2. Theprosthetic device of claim 1, wherein the shape memory alloy is nickeltitanium.
 3. The prosthetic device of claim 1, wherein the support stentis formed with an expandable mesh construction.
 4. The prosthetic deviceof claim 1, wherein the mesh construction is web-like.
 5. The prostheticdevice of claim 1, wherein the three valve leaflets are spaced apartfrom an net end of the support stent.
 6. The prosthetic device of claim1, wherein the support stent is collapsible to a delivery diameter sizedfor advancement through a femoral artery.
 7. The prosthetic device ofclaim 1, further comprising a collapsible and expandable sheath suturedto the first portion of the support stent.
 8. A prosthetic device forreplacing a deficient native aortic valve, comprising: a metallic,annular support stent having a circular outer profile and collapsible toa delivery diameter sized for advancement through a femoral artery, thesupport stent comprising: a lower portion formed with an expandable meshconstruction and configured to expand to a first expanded diameterdimensioned to contact the leaflets of a native aortic valve, an upperportion formed with an expandable mesh construction, the upper portionbeing configured to contact the inner wall of the ascending aorta at alocation above the openings of the coronary arteries, the upper portionhaving a second expanded diameter, and a central portion between thelower and upper portions, the central portion being shaped to provide aradial gap between the support stent and the inner wall of the ascendingaorta adjacent to the openings of the coronary arteries; and acollapsible and expandable valve assembly located entirely within aninterior portion of the support stent and formed of biological material,the valve assembly sutured to the support stent, the valve assemblyhaving three commissural points for supporting three valve leafletswithin the support stent; wherein the three leaflets of the valveassembly are configured to open for allowing blood to flow from the leftventricle into the ascending aorta, and wherein the three leaflets ofthe valve assembly collapse inwardly for blocking a reverse flow ofblood and wherein the support stent has an open wall structuredownstream of the leaflets for allowing blood to pass through a wall ofthe support stent from the interior portion of the support stent to theopenings of the coronary arteries, and wherein the first expandeddiameter of the lower portion of the support stent is smaller than thesecond expanded diameter of the upper portion of the support stent. 9.The prosthetic device of claim 8, wherein the metallic support stent isformed of a shape memory alloy.
 10. The prosthetic device of claim 9,wherein the shape memory alloy is nickel titanium.
 11. The prostheticdevice of claim 8, further comprising a collapsible and expandablesheath sutured to the lower portion of the support stent.
 12. Theprosthetic device of claim 8, wherein the three valve leaflets arespaced apart from an inlet end of the support stent.
 13. A prostheticdevice for replacing a deficient native aortic valve, consistingessentially of: a collapsible and expandable, annular support stentcomprising a nickel-titanium shape memory alloy, the support stentcomprising a circular outer profile, a first portion, a second portion,and a central portion extending between the first portion and the secondportion, the second portion being downstream from the first portion; acollapsible and expandable valve assembly comprising biological materialand disposed within an interior of the support stent, the valve assemblycomprising an inlet region sutured to the support stent and threecommissural points sutured to the support stent, the three commissuralpoints defining three valve leaflets; and a collapsible and expandablesheath disposed at and sutured to the first portion of the supportstent; wherein the prosthetic device has a collapsed, delivery state andan expanded, deployed state, wherein, in the expanded, deployed state,an expanded diameter of the first portion of the support stent issmaller than an expanded diameter of the second portion of the supportstent, the first portion of support stent is dimensioned to contact theleaflets of the native aortic valve, the first portion of the supportstent is configured and dimensioned to not substantially deform aneighboring mitral valve, the central portion of the support stentdefines a radial gap between the support stent and an inner wall of anascending aorta at a level of the coronary ostia, the second portion ofthe support stent is configured and dimensioned to engage the inner wallof the ascending aorta above the coronary ostia, the support stentcomprises an open-wall structure downstream of the valve assembly,thereby allowing blood to pass from the interior of the support stent tothe coronary ostia, and the three leaflets of the valve assembly have anopen state that allows a forward flow of blood from the left ventricleinto the ascending aorta, and a closed state that blocks a reverse flowof blood, in which the three leaflets are collapsed inwardly, andwherein in the collapsed, delivery state, the device is dimensioned foradvancement through a femoral artery.
 14. The prosthetic device of claim13, wherein the support stent comprises an expandable mesh construction.15. The prosthetic device of claim 14, wherein the mesh construction isweb-like.
 16. The prosthetic device of claim 13, wherein the sheath issecured to an outside surface of the support stent.